Bioprocessing Poster

Proof that can travel – Documented clonality report for regulatory submission

Clonality is a key element of cell line development and is an important component of a regulatory submission. Indeed for BLA, the clonality of MCB is mandatory. Historically, the regulator has insisted upon 2 rounds of cloning for developing a cell line and assurance of monoclonality based on statistical outgrowth measurements. Recent improvements in high resolution whole well imaging of cells in microplates, enables the creation of indisputable image based evidence for the growth of a colony from a single cell. This evidence eliminates a round of sub-cloning and results in several weeks of cell line development time being saved. However, current compilation of images using ‘cut and paste’ into a report is laborious, error-prone and difficult to audit.

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